December 6, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported it will present new data demonstrating the benefits of using the Guardant360 liquid biopsy test to help guide targeted therapy options for patients with advanced breast cancer at the 2021 San Antonio Breast Cancer Symposium (SABCS) on December 7-11 (Press release, Guardant Health, DEC 6, 2021, View Source [SID1234596514]). These studies were based on data from the GuardantINFORM real-world clinical genomic platform, which features extensive de-identified genomic data and aggregated commercial payer claims from advanced cancer patients who received the Guardant360 liquid biopsy assay.

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Data from one study (Abstract P5-13-29) confirmed that patients with BRCA1/2 reversion mutations, thought to cause acquired therapeutic resistance, experienced worse survival outcomes when treated with a PARP inhibitor as compared to patients without reversion mutations. The study also validates recent advancements in homologous recombination deficiency (HRD) assessment in the Guardant360 lab developed test (LDT), detecting additional inactivating alterations in BRCA1/2, including copy number loss and large genomic rearrangements. These data further demonstrate the Guardant360 test’s ability to reliably identify patients with advanced breast cancer who are most likely to benefit from PARP inhibitor treatment.

Another study (Abstract P1-18-07) using the GuardantINFORM platform demonstrated that, for advanced breast cancer patients with PIK3CA mutations identified using the Guardant360 liquid biopsy and subsequently treated with alpelisib, there was no significant difference in treatment outcomes regardless of whether they had clonal or subclonal PIK3CA mutations. This suggests patients with these mutations may benefit from alpelisib targeted therapy irrespective of mutation clonality.

"These studies further support the tremendous value that our Guardant360 liquid biopsy test and GuardantINFORM real-world clinical genomic platform bring to physicians, and most importantly the patients they treat," said Helmy Eltoukhy, Guardant Health Co-CEO. "Guardant360 identifies mutations driving the cancer, which enables the physician to match a patient with the right precision therapy without the need for a tissue biopsy, which can be difficult and time-consuming, potentially delaying treatment for patients with advanced breast cancer."

Full List of Guardant Health Presentations:

Analytical and clinical validation of a ctDNA assay for detecting copy number loss and structural rearrangement variants contributing to homologous recombination and repair (HRR) deficiency (Abstract Number: P5-13-29)
Impact of PIK3CA mutation (PIK3CA-mt) clonality on alpelisib (ALP) activity based on real-world evidence (RWE) following liquid biopsy testing (Abstract Number: P1-18-07)
SOLTI-1903 HOPE: Real-world clinical practice study to assess the impact of using genomic data on the next treatment decision making-choice in patients with locally advanced or metastatic breast cancer in Spain (Abstract Number: OT2-06-01)
Early changes in circulating tumor DNA and its effect on clinical outcomes in patients with advanced breast cancer receiving the CDK4/6 inhibitor palbociclib: Genotyping results from POLARIS (Abstract Number: P1-18-05)
The full abstracts can be found at the official SABCS website here.

About the Guardant360 Liquid Biopsy Test

The Guardant360 liquid biopsy test is part of the market leading Guardant360 portfolio that offers oncologists end-to-end testing solutions from treatment selection to treatment response monitoring. Since it was first introduced, the Guardant360 liquid biopsy test has become widely accepted for blood-based comprehensive genomic profiling (CGP) with more than 250 peer-reviewed publications including over 60 clinical outcomes studies. It has been trusted by more than 9,000 oncologists with more than 200,000 tests performed to date.

About GuardantINFORM

The GuardantINFORM clinical-genomic platform is intended to help accelerate research and development of the next generation of cancer therapeutics by offering biopharma partners an in-silico platform that combines de-identified longitudinal clinical information and genomic data collected from the Guardant360 liquid biopsy test. With data from more than 160,000 patients diagnosed with locally advanced and metastatic cancers, this robust dataset offers real-world insights into anti-cancer therapy use in the clinic, tumor evolution, and treatment resistance throughout each patient’s treatment journey for many advanced solid tumor cancers, including non-small cell lung, breast, colon, and prostate.

On December 6, 2021 BostonGene Corporation, a biomedical software company committed to defining optimal precision medicine-based therapies for cancer patients, reported that seven abstracts were selected for presentations at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, BostonGene, DEC 6, 2021, View Source [SID1234596513]). The event will be held from December 11 – 14, 2021 at the Georgia World Congress Center. BostonGene will exhibit in booth #3765.

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"We’re honored to have multiple presentations accepted by the ASH (Free ASH Whitepaper) Program Committee. Our presentations underscore the power of integrated analysis to discover distinct characteristics of the tumor microenvironment associated with clinical outcome to diverse therapeutic regimens in lymphoma," said Nathan Fowler, MD, Chief Medical Officer at BostonGene.

Details of the oral and poster presentations are below:

Oral presentations:

Title: High Rates of Remission with the Initial Treatment of Oral Azacitidine Plus CHOP for Peripheral T-Cell Lymphoma (PTCL): Clinical Outcomes and Biomarker Analysis of a Multi-Center Phase II Study
Abstract Number: 138
Session: 624. Hodgkin Lymphomas and T/NK cell Lymphomas
Time and Location: Saturday, December 11, 2021: 1:15 PM, Thomas Murphy Ballroom 3-4
Presenter: Jia Ruan, MD, PhD, Weill Cornell Medicine and New York Presbyterian Hospital

Research conducted by Weill Cornell Medicine, Memorial Sloan Kettering Cancer Center, Washington University School of Medicine, Moffitt Cancer Center and BostonGene.

Title: Phase 2 Study of Acalabrutinib Window Prior to Frontline Therapy in Untreated Aggressive B-Cell Lymphoma: Preliminary Results and Correlatives of Response to Acalabrutinib
Abstract Number: 524
Session: 626. Aggressive Lymphomas Prospective Therapeutic Trials
Time and Location: Sunday, December 12, 2021: 4:45 PM, Thomas Murphy Ballroom 1-2
Presenter: Mark Roschewski, MD, National Cancer Institute, National Institutes of Health

Research conducted by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), both part of the National Institutes of Health (NIH), Stanford University and BostonGene.

Title: The Combination of Duvelisib and Romidepsin (DR) Is Highly Active Against Relapsed/Refractory Peripheral T-Cell Lymphoma with Low Rates of Transaminitis: Final Results and Biomarker Analysis
Abstract Number: 619
Session: 624. Hodgkin Lymphomas and T/NK cell Lymphomas
Time and Location: Monday, December 13, 2021: 10:30 AM, Hall A1
Presenter: Steven Horwitz, MD, Memorial Sloan Kettering Cancer Center

Research conducted by Memorial Sloan Kettering Cancer Center, Dana Farber Cancer Institute, Harvard Medical School, Washington University in St. Louis, Stanford University and BostonGene.

Poster presentations:

Title: HHV-6 in the Lymphoma Microenvironment: Both Chicken and Egg?
Abstract Number: 1377
Session: 624. Hodgkin Lymphomas and T/NK cell Lymphomas
Time and Location: Saturday, December 11, 2021: 5:30 PM – 7:30 PM
Presenter: Genevieve Crane, MD, PhD, Cleveland Clinic

Research conducted by Weill Cornell Medicine, Cleveland Clinic, Memorial Sloan Kettering Cancer Center, Columbia University and BostonGene.

Title: Immune-Depleted Tumor Microenvironment Signature Is Associated with BTK Inhibitor Resistance in Mantle Cell Lymphoma
Abstract Number: 1321
Session: 621. Lymphomas: Translational—Molecular and Genetic
Time and Location: Saturday, December 11, 2021: 5:30 PM – 7:30 PM, Hall B5
Presenter: Preetesh Jain, MBBS, MD, DM, PhD, The University of Texas MD Anderson Cancer Center

Research conducted by MD Anderson and BostonGene.

Title: A Prospective Study of Clonal Evolution in Follicular Lymphoma: Circulating Tumor DNA Correlates with Overall Tumor Burden and Fluctuates over Time without Therapy
Abstract Number: 524
Session: 621. Lymphomas
Time and Location: Saturday, December 11, 2021, 5:30 PM – 7:30 PM, Hall B5
Presenter: Allison Distler, National Cancer Institute, National Institutes of Health and George Washington University

Research conducted by the National Cancer Institute (NCI), National Institutes of Health (NIH), George Washington University, Adaptive Biotechnologies and BostonGene.

Title: Topographic Analysis of Low-Grade Myeloid Neoplasms By Multiparametric in Situ Imaging of Human Bone Marrow Core Biopsy Tissues
Abstract Number: 2593
Session: 636. Myelodysplastic Syndromes—Basic and Translational
Time and Location: Sunday, December 12, 2021: 6:00 PM – 8:00 PM, Hall B5
Presenter: Sanjay Patel, MD, MPH, MSc, Weill Cornell Medicine

Research conducted by Weill Cornell Medicine and BostonGene.

In addition to the oral and poster presentations, the abstracts have been published online in the November supplemental issue of "Blood".

On December 6, 2021 Paige, the global leader in AI-based diagnostic software in pathology, reported it will present new data demonstrating the performance of Paige Breast "Beta" in detecting various forms of breast cancer and highlight the accuracy of a new AI-based system that detects invasive lobular carcinoma (ILC), the most frequent subtype of breast cancer (Press release, Paige AI, DEC 6, 2021, View Source [SID1234596512]). The data will be featured during a Spotlight Poster Discussion at the upcoming 2021 San Antonio Breast Cancer Symposium (SABCS 2021), taking place virtually and in-person at the Henry B. Gonzalez Convention Center in San Antonio, Texas from December 7-10, 2021.

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An artificial intelligence-based predictor of CDH1 biallelic mutations and lobular carcinoma
Authors: Jorge S. Reis-Filho, et al.
Session: Spotlight Poster Discussion 11 – The future is now: Innovation in pathology and radiology
Poster #: PD11-01
Date and Time: Thursday, December 9, 2021; 5:00 p.m. – 6:30 p.m. CST
Location: Stars at Night Ballroom 3&4
Subtyping invasive carcinomas and high-risk lesions for Machine-Learning-Based Breast Pathology
Authors: Matthew G. Hanna, et al.
Session: Spotlight Poster Discussion 11 – The future is now: Innovation in pathology and radiology
Poster #: PD11-02
Date and Time: Thursday, December 9, 2021; 5:00 p.m. – 6:30 p.m. CST
Location: Stars at Night Ballroom 3&4
Additionally, Thomas J. Fuchs, Dr.Sc., Chief Scientist and Founder of Paige, will discuss the implications of AI technology in pathology during an educational session titled "Artificial Intelligence: Beyond the Soundbites," moderated by Jorge S. Reis-Filho, M.D., Ph.D., Principal of Biomarker Development at Paige and Chief of Experimental Pathology Service at Memorial Sloan Kettering Cancer Center. Details are below:

Artificial intelligence: Guiding the pathologists’ eyes
Presenter: Thomas J. Fuchs
Session: Educational Sessions
Date and Time: Tuesday, December 7, 2021; 5:00 p.m. – 7:00 p.m. CST
Location: Stars at Night Ballroom 3&4
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On December 6, 2021 Helio Health ("Helio") and its commercial partner, Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent"), reported the commercial launch of HelioLiver, a multi-analyte blood test that incorporates cell free DNA (cfDNA) methylation patterns and serum protein markers for the detection of hepatocellular carcinoma (HCC) – the most common form of liver cancer (Press release, Fulgent Genetics, DEC 6, 2021, View Source [SID1234596511]). HelioLiver can detect HCC at its earliest stages when lesions are still very small, an area where traditional standard-of-care imaging tools often fall short, with the potential to enable more curative treatment options known to increase five-year survival rates by up to 13 times compared to when cancer has metastasized.1,2

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Recent data presented at The Liver Meeting 2021 outlined HelioLiver’s superior sensitivity over currently available blood-based tests. With a specificity of 91%, HelioLiver demonstrated 76% sensitivity in detecting early-stage HCC, significantly outperforming other detection tools such as AFP (57%), GALAD (65%), and ultrasound (47%).3,4

"We are excited to offer patients at high risk of developing liver cancer a convenient and sensitive serial testing option to catch cancer early when it counts the most," said Justin Chen Li, U.S. Chief Executive Officer, Helio Health. "We are proud to partner with Fulgent to launch this innovative, simple, and reliable test that has the potential to redefine the future of cancer testing and foster better patient outcomes."

HelioLiver offers a simplified process for patients with a blood draw that can be conducted during a routine check-up, providing a quick and accurate way to receive regular surveillance for people at risk of developing liver cancer. While the American Association for the Study of Liver Diseases (AASLD) guidelines recommend ultrasound screening every six months for patients who are at risk, studies have shown that as few as 20% of patients actually receive regular surveillance due to the inconvenience of accessing testing via ultrasound.5 Helio believes this number can dramatically increase with this new, blood-based test.

"Through our partnership with Helio, our joint priority is to bring HelioLiver to providers and patients in a seamless manner," said Brandon Perthuis, Chief Commercial Officer, Fulgent Genetics. "Leveraging our extensive commercial infrastructure, we are well-positioned to deliver an easy ordering experience for providers with our representatives at the ready to provide the best-in-class white glove service throughout the entire experience."

Providers can place orders online at HelioLiver.com/how-to-order, via phone (+1 626-350-0537) or email at [email protected] to get connected with a representative.

For more information about HelioLiver and its clinical performance, please visit www.HelioLiver.com.

On December 6, 2021 Novocure (NASDAQ: NVCR) reported the 4th Annual AACR (Free AACR Whitepaper)-Novocure Grants for Tumor Treating Fields Research Program. The program represents a joint effort with the American Association for Cancer Research (AACR) (Free AACR Whitepaper) to promote and support innovative research on Tumor Treating Fields (TTFields) to help deepen the understanding of the mechanism of action and to accelerate the development of new treatment strategies (Press release, NovoCure, DEC 6, 2021, View Source [SID1234596510]). The program includes research grants and career development awards totaling more than $2 million over the next three years.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The research grants will include five AACR (Free AACR Whitepaper)-Novocure Tumor Treating Fields Research Grants and two AACR (Free AACR Whitepaper)-Novocure Career Development Awards for Tumor Treating Fields Research. Recipients of the research grants will receive a total of $250,000 over two years. Recipients of the career development awards will receive a total of $225,000 over three years.

"We are thrilled to continue our partnership with Novocure," said Mitch Stoller, the AACR (Free AACR Whitepaper)’s Chief Philanthropic Officer. "These two grant mechanisms represent an important means for advancing the science of TTFields research and attracting talented investigators. We once again look forward to learning about the outstanding projects that will result from these grants and to meeting next year’s class of grantees."

Novocure and the AACR (Free AACR Whitepaper) encourage applicants to focus their proposals on translational approaches, promoting the transition of in vitro work into in vivo systems; combination therapies involving Tumor Treating Fields; and bringing treatments involving Tumor Treating Fields to the clinic. The application deadline is January 20. Recipients will be announced in April at the AACR (Free AACR Whitepaper) Annual Meeting 2022 in New Orleans.

"Deepening our understanding of the mechanism of action of Tumor Treating Fields can potentially advance our efforts to extend survival in some of the most aggressive forms of cancer," said Dr. Uri Weinberg, Novocure’s Chief Science Officer. "We are excited to partner with the AACR (Free AACR Whitepaper) to offer this innovative research program for the fourth year and look forward to the announcement of recipients at the AACR (Free AACR Whitepaper) Annual Meeting."

To apply for the AACR (Free AACR Whitepaper)-Novocure Grants for Tumor Treating Fields Research, visit www.aacr.org/funding.

About Tumor Treating Fields

Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division. Fundamental scientific research on TTFields extends across more than two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. TTFields therapy is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields therapy has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, including four phase 3 pivotal trials in a variety of tumor types. To date, more than 20,000 patients have been treated with TTFields therapy.